Clearance Summary
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E received FDA 510(k) clearance under submission number K090914, sponsored by Xoft, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-07-16.
- Submission: K090914
- Applicant / Sponsor: Xoft, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5900
- Decision date: 2009-07-16
Classification & Regulation
This clearance is catalogued under FDA product code JAD and 21 CFR 892.5900, within the Radiology review panel as a Class II device.